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EHR CertificationRequirements for Medical Practices 4Dr Inc. www.4Drinc.com Michael Patrick 1
HIT Policy Committee Recommendations by the Certification and Adoption Workgroup Paul Egerman Marc Probst, Intermountain Healthcare July 16, 2009
Agenda The Workgroup’s Charge Initial Recommendations Questions Answered Next Steps 3 www.4drinc.com
The Workgroup Charge Broad Charge - Make recommendations to the HIT Policy Committee on issues related to the adoption of certified electronic health records that support meaningful use, including issues related to certification, health information extension centers and workforce training. Current focus of this report – review the existing certification and standards setting processes and make recommendations to the HIT Policy Committee, within four (4) months of the initial meeting of the workgroup, about how these processes should be structured in the future. 4 www.4drinc.com
Workgroup Process Through a series of teleconferences and meetings: Developed understanding of existing certification processes and issues Defined questions to be asked of solution providers and users (current/future) Workgroup members solicited input and aggregated information received Discussed and commented on information gathered Defined initial set of recommendations Two–day testimony (July 14th/15th) Reviewed initial comments submitted Developed recommendations to the HIT Policy Committee 5 www.4drinc.com
Purpose of Certification Proposed Definition of HHS Certification 	HHS Certification means that a system is able to achieve government requirements for security,  privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects.   	HHS Certification is not intended to be viewed as a “seal of approval” or an indication of the benefits of one system over another.  6 www.4drinc.com
Recommendations Focus Certification on Meaningful Use Leverage Certification process to improve progress on Security, Privacy, and Interoperability  Improve objectivity and transparency of the certification process Expand Certification to include a range of software sources: Open source, self-developed, etc.  Develop a Short-Term Transition plan 7 www.4drinc.com
Recommendation 1 – Focus on Meaningful Use The National Coordinator should determine the criteria for HHS Certification, which should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and  (b) achieve the Meaningful Use Objectives. The focus on Meaningful Use should reduce the barriers currently faced by vendors that focus on specialists. Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit. These criteria should be updated as the definition of meaningful use evolves.  The Workgroup encourages the industry to continue to provide advisory services that can rate other aspects of EHRs that are important to purchasers, e.g., non-meaningful use features and functions and vendor viability and support capabilities. The Office of the National Coordinator (ONC) is encouraged to explore critical aspects of EHRs for which certification criteria may not exist today, e.g., usability and improved models for system and data architecture. 8 www.4drinc.com
Recommendation 2 – Progress on Security, Privacy, and Interoperability HHS Certification must specifically include requirements addressing all privacy and security policies described in ARRA. ONC should develop tighter integration between standards and certification. If necessary, ONC should commission (not just harmonize) the development of standards. Aggressively establish new, very specific requirements for Interoperability and data exchange.  Create “test harnesses” that will enable providers and health care organizations to easily self-test the software to validate the product and test it against established interoperability standards. Prioritize focusing on criteria for interoperability and data exchange for systems/applications that interchange data with a certified EHR. 9 www.4drinc.com
Recommendation 3 – Objective and Transparent Process The process of defining HHS Certification criteria should be performed by ONC, and separated from organizations that perform certification testing. The establishment of criteria and associated standards must be done in a transparent fashion. In making decisions about HHS Certification criteria, the National Coordinator should rely on the Policy and Standards Committees for guidance.   Working with NIST, ONC should develop a comprehensive process for conformity assessment including testing, certification, accreditation and surveillance.  ONC should develop an accreditation process and select an organization to accredit certifying organizations. Multiple organizations should be allowed to perform HHS Certification testing and provide certification. (Vendors will need to get certification only from one certifying organization.) This updating should occur no more frequently than every other year and be done in time to allow EHR suppliers and adopters sufficient time for effective implementation. 10 www.4drinc.com
Recommendation 4 – Flexible Software Sources ONC should provide certification support to a wide range of EHR sources to support the “mandatory” nature of incentive payments based on Meaningful Use. Certification of components should be available so providers can achieve Meaningful Use with implementation of these components. All EHRs should be certified. The “lock down” requirements of EHR software should be removed to address concerns of the Open Source community. For self-developed software, an alternate certification process could be provided based upon site inspection. 11 www.4drinc.com
Recommendation 5 – Short Term Transition ONC should define missing criteria to address Meaningful Use objectives, e.g., public health. ONC should revise the existing criteria to meet Meaningful Use objectives, e.g., e-prescribing.  Subject to completing a special MU Gap Certification, existing certified products should be deemed certified for 2011. New products, not currently certified, should be certified against the revised criteria and gaps. Until the new HHS Certification process is established, with ONC approval, CCHIT should continue to perform certifications against ONC defined criteria. 12 www.4drinc.com
Next Steps Present initial recommendations (today) Open for Public Comment Review Public Comment Refine recommendations Deliver Certification recommendations to HIT Policy Committee 13 www.4drinc.com
Summary Meaningful use requirement will drive certification. Existing certification bodies, CCHIT, will have a diminished role in certification. Certification will evolve over time. Current certified products should be qualified for the 2011 stimulus bill funds for EHR. www.4drinc.com can provide education for medical practices picking an EHR vendor. 14 www.4drinc.com

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EHR Certification Requirements for Medical Practices

  • 1. EHR CertificationRequirements for Medical Practices 4Dr Inc. www.4Drinc.com Michael Patrick 1
  • 2. HIT Policy Committee Recommendations by the Certification and Adoption Workgroup Paul Egerman Marc Probst, Intermountain Healthcare July 16, 2009
  • 3. Agenda The Workgroup’s Charge Initial Recommendations Questions Answered Next Steps 3 www.4drinc.com
  • 4. The Workgroup Charge Broad Charge - Make recommendations to the HIT Policy Committee on issues related to the adoption of certified electronic health records that support meaningful use, including issues related to certification, health information extension centers and workforce training. Current focus of this report – review the existing certification and standards setting processes and make recommendations to the HIT Policy Committee, within four (4) months of the initial meeting of the workgroup, about how these processes should be structured in the future. 4 www.4drinc.com
  • 5. Workgroup Process Through a series of teleconferences and meetings: Developed understanding of existing certification processes and issues Defined questions to be asked of solution providers and users (current/future) Workgroup members solicited input and aggregated information received Discussed and commented on information gathered Defined initial set of recommendations Two–day testimony (July 14th/15th) Reviewed initial comments submitted Developed recommendations to the HIT Policy Committee 5 www.4drinc.com
  • 6. Purpose of Certification Proposed Definition of HHS Certification HHS Certification means that a system is able to achieve government requirements for security, privacy, and interoperability, and that the system would enable the Meaningful Use results that the government expects. HHS Certification is not intended to be viewed as a “seal of approval” or an indication of the benefits of one system over another. 6 www.4drinc.com
  • 7. Recommendations Focus Certification on Meaningful Use Leverage Certification process to improve progress on Security, Privacy, and Interoperability Improve objectivity and transparency of the certification process Expand Certification to include a range of software sources: Open source, self-developed, etc. Develop a Short-Term Transition plan 7 www.4drinc.com
  • 8. Recommendation 1 – Focus on Meaningful Use The National Coordinator should determine the criteria for HHS Certification, which should be limited to the minimum set of criteria that are necessary to: (a) meet the functional requirements of the statute, and (b) achieve the Meaningful Use Objectives. The focus on Meaningful Use should reduce the barriers currently faced by vendors that focus on specialists. Criteria on functions/features should be high level; however, criteria on interoperability should be more explicit. These criteria should be updated as the definition of meaningful use evolves. The Workgroup encourages the industry to continue to provide advisory services that can rate other aspects of EHRs that are important to purchasers, e.g., non-meaningful use features and functions and vendor viability and support capabilities. The Office of the National Coordinator (ONC) is encouraged to explore critical aspects of EHRs for which certification criteria may not exist today, e.g., usability and improved models for system and data architecture. 8 www.4drinc.com
  • 9. Recommendation 2 – Progress on Security, Privacy, and Interoperability HHS Certification must specifically include requirements addressing all privacy and security policies described in ARRA. ONC should develop tighter integration between standards and certification. If necessary, ONC should commission (not just harmonize) the development of standards. Aggressively establish new, very specific requirements for Interoperability and data exchange. Create “test harnesses” that will enable providers and health care organizations to easily self-test the software to validate the product and test it against established interoperability standards. Prioritize focusing on criteria for interoperability and data exchange for systems/applications that interchange data with a certified EHR. 9 www.4drinc.com
  • 10. Recommendation 3 – Objective and Transparent Process The process of defining HHS Certification criteria should be performed by ONC, and separated from organizations that perform certification testing. The establishment of criteria and associated standards must be done in a transparent fashion. In making decisions about HHS Certification criteria, the National Coordinator should rely on the Policy and Standards Committees for guidance. Working with NIST, ONC should develop a comprehensive process for conformity assessment including testing, certification, accreditation and surveillance. ONC should develop an accreditation process and select an organization to accredit certifying organizations. Multiple organizations should be allowed to perform HHS Certification testing and provide certification. (Vendors will need to get certification only from one certifying organization.) This updating should occur no more frequently than every other year and be done in time to allow EHR suppliers and adopters sufficient time for effective implementation. 10 www.4drinc.com
  • 11. Recommendation 4 – Flexible Software Sources ONC should provide certification support to a wide range of EHR sources to support the “mandatory” nature of incentive payments based on Meaningful Use. Certification of components should be available so providers can achieve Meaningful Use with implementation of these components. All EHRs should be certified. The “lock down” requirements of EHR software should be removed to address concerns of the Open Source community. For self-developed software, an alternate certification process could be provided based upon site inspection. 11 www.4drinc.com
  • 12. Recommendation 5 – Short Term Transition ONC should define missing criteria to address Meaningful Use objectives, e.g., public health. ONC should revise the existing criteria to meet Meaningful Use objectives, e.g., e-prescribing. Subject to completing a special MU Gap Certification, existing certified products should be deemed certified for 2011. New products, not currently certified, should be certified against the revised criteria and gaps. Until the new HHS Certification process is established, with ONC approval, CCHIT should continue to perform certifications against ONC defined criteria. 12 www.4drinc.com
  • 13. Next Steps Present initial recommendations (today) Open for Public Comment Review Public Comment Refine recommendations Deliver Certification recommendations to HIT Policy Committee 13 www.4drinc.com
  • 14. Summary Meaningful use requirement will drive certification. Existing certification bodies, CCHIT, will have a diminished role in certification. Certification will evolve over time. Current certified products should be qualified for the 2011 stimulus bill funds for EHR. www.4drinc.com can provide education for medical practices picking an EHR vendor. 14 www.4drinc.com

Editor's Notes

  1. Welcome to another 4Dr slidecast on EHR for medical practices. Today I’m going to speak about the latest information on “certified” EHR technology.We will focus on the criteria a medical practice should use to select an EHR vendor.My name is Michael Patrick and I’m a principal of 4Dr.
  2. On July 16th, 2009, the Certification and Adoption Workgroup presented its initial recommendation for certification to the Office of National Coordinator’s Policy Committee.The workgroup held public hearings on July 14th and 15th and then presented its findingsto the Policy committee.
  3. The slides presented come directly from the Workgroup’s presentation. They provide an excellent roadmap for funding qualification.I have removed some slides to get to the meat of the matter, but have not edited any of the wording.The summary at the end is my own.
  4. This workgroup is one of several under the Office of National Coordinator’s Policy Committee.Their purpose is to make recommendation on “certifying” EHR technology as it relates to the stimulus bill. As we all know, the two key requirements for providers to qualify for EHR stimulus bill payments are the use of “certified technology” and the “meaningful use” of the technology.For more information on meaningful use, please view my slidecast at www.4drinc.com.The goal of the workgroup is to have the certification process defined within four months.
  5. The workgroup through a series of fact finding meetings with providers, solutions vendors andcertification authorities developed 5 areas of recommendations.These recommendations are the focus of this presentation.
  6. Before the recommendations, let’s talk about the purpose of certification.The use of certification is to insure to HHS that meaningful use is achievable by a vendor solution. The certification will also address security and privacy of the patient information andalso the importance of the ability to securely exchange patient information between providers and payers.Certification is not intended to be a “seal of approval” or provide a ranking of solutions.
  7. The workgroup arrived at 5 general recommendations.First, is to link certification and meaningful use. This is a clear message for vendors and users.Second, use certification to drive security and privacy and data exchange between different solutions.Third, allow for the certification process to be objective and transparent. Some circles believethat the current certification process is biased toward vendors.Fourth, include open source and self developed solutions in the certification process. This recommendation is least important to small/medium private practices.Lastly, provide short term transition certification plans to meet the 2011 milestone set by the stimulus bill.
  8. Meaningful use is King. The ability to use the system in a beneficial way will trump feature/function. Interoperability between disparate systems needs to be moved up in importance and development of specific standards for interoperability need a renewed focus.Certification criteria will evolve in tandem with the evolution of meaningful use.
  9. All of the privacy and security policies listed in the stimulus bill must be addressed viacertification.A concern has been the lack of facilities to promote the interoperability and data exchange of patient data . This workgroup will aggressively establish new requirements for interoperability.A key requirement in selecting an EHR vendor is their ability to exchange data withother providers and data exchanges.
  10. Development of certification criteria should be under the authority of ONC. Separatecertification testing organization should not develop criteria but specifically providetesting mechanism for the ONC criteria. This will result in a transition of responsibilityfor the existing certification organization, CCHIT.Multiple certification testing organizations will be encouraged by the ONC, but vendors need only one organization to certify their technology.Updating certification criteria should occur every other year to allow sufficient time for vendors and providers to effectively comply to the new certification requirements.
  11. The workgroup heard complaints from the Open Source advocates that the current certificationprocess doesn’t include those providers that use an open source EHR. While this doesn’t apply to the vast majority of small/medium providers it is important to largerhealth care institutions
  12. There is a concern in some ranks that the 2011 date as the first year of meaningful use for EHR qualifications is unachievable.This slide sends the message that HHS is going to meet the 2011 date.Those products that are currently CCHIT certified will be deemed certified for 2011 subject toa Meaningful Use Gap certification. This gap certification will be achieved by the vendor. Thismean that if your practice is looking at purchasing EHR technology it is imperative that it beCCHIT 2008 certified.If a product is not certified currently, then it needs to be certified by still undecided criteria.Until the new HHS certification process is in place, CCHIT should continue certification using the ONC defined criteria.
  13. The workgroup has committed to the ONC that it will have the certification recommendationto the Policy Committee by November. It is now open for public comment on its initial recommendations and it will review the comments and refine its recommendations to the Policy committee.
  14. It is refreshing to see a governmental organization moving in an aggressive manner.So far the Policy Committee has signaled its willingness to drive toward the 2011 date.It also has sent clear signals on meaningful use and certification.Meaningful use requirements will drive certification.Existing certification bodies, CCHIT, will have a diminished role in certification but will stillprovide a focus in the short term and transition to a testing organization over time.Certification requirements will evolve every two years.Current certified products should be qualified for the 2011 stimulus bill funds for EHR. So makesure your vendor has achieved CCHIT 2008 certification.For more information on EHR and medical practices go to:www.4drinc.com